Continuation of medical devices: product id 4351-35, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2016, product type lead.Product id 4351-35, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2016, product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 04-oct-2015, udi#: (b)(4); product id: 4351-35, serial/lot #: (b)(4), ubd: 07-nov-2015, udi#: (b)(4).(b)(4).Pertain to product id 4351-35 serial# (b)(4) product type lead and product id 4351-35 serial# (b)(4) product type lead.Occupation: non-healthcare professional.If information is provided in the future, a supplemental report will be issued.
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Information was received from a consumer regarding a patient with an implantable neurostimulator (ins).It was reported that since implant, the patient could feel the stimulation pulsation in their stomach, which caused pain to shoot to their left arm and shoulder.It was noted that the patient¿s healthcare provider (hcp) originally told the patient that the patient was just imagining it, but later the hcp told the patient that they started implanting the leads in the back of the stomach instead of the front because the front location was near a nerve and they found that stimulation delivered near that nerve would cause painful stimulation to the left arm area.The patient had the system replaced and the lead location revised from the front of the stomach to the rear; it was noted that the sensation stopped as soon as the hcp did this.No further complications were reported/anticipated.
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